to evaluate the effect of a probiotic formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability, microbiota, cytokines and chemokines expression and other inflammatory markers in pediatric patients with Crohn's Disease
To determine the effect on Pediatric Crohn Disease Activity Index (PCDAI);
to determine the time till flare of CD pediatric patients on VSL#3 compared to placebo.
5 Years to 17 Years (Child)
July 3, 2012
August 12, 2014
University of Naples "Federico II" Naples, Italy
† Study has passed its completion date and status has not been verified in more than two years.